Senior Manager, QA & Compliance

Job Description
Job Responsibilities:

• Assure all systems, processes and their outcomes comply with standards that meet applicable international and national regulations and guidelines, and fulfill client and Covance requirements.

• Assure that all projects for which Global QA Lead responsibilities have been assigned have an audit strategy agreed and documented in the QA&C central planning system.

• Assist with the allocation of QA&C staff to complete the required audits.

• Assure that audits as defined in the global audit plan are completed on time and within budget including reporting and follow up to closure.

• Provide local leadership and line management as required.

• Perform audits.

• Lead and participate in special projects.

• Contribute to process improvement initiatives across organization.

• Represent QA on project teams, management meetings, and other internal forums as well as client meetings and audits.

• Participate in negotiations with clients.

• Contribute to the preparation of Time and Cost Estimates as requested.

Role will require ~ 30% travel, primarily domestic but may include international as applicable

Education/Qualifications

• University/college degree, BA/BS (life science preferred) or equivalent experience.

• Advanced degree (e.g. postgraduate qualification in quality assurance) or equivalent experience.

• Strong analytical skills.

• Knowledge, understanding and experience in applying ICH/FDA Good Clinical
Practices.

• Excellent oral, written and presentation skills.

• Excellent planning and organizational skills.

• Proven interpersonal skills.

• Demonstrated ability to handle multiple competing priorities across clinical operating units.

• Ability to inspire effective teamwork and motivate staff within a matrix system.

• Ability to function as a member of a global clinical team.

Experience •4 Years experience in Clinical Quality Assurance, preferably with GCP experience.

•7 Years experience in other professional roles within pharmaceutical/CRO environment.
Other required work-related experiences:

•Proven ability to understand, analyze and communicate the impact of global regulatory issues affecting the drug development process.

• Financial understanding of global clinical development budgets.

• Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.

• Knowledge of the drug development process from the perspective of a contract research organization.

Company

Covance Laboratories

Job Code

State or Province

New Jersey

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